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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETAMINOPHEN\ASPIRIN\CAFFEINE: 11,702 Adverse Event Reports & Safety Profile

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11,702
Total FAERS Reports
155 (1.3%)
Deaths Reported
438
Hospitalizations
11,702
As Primary/Secondary Suspect
121
Life-Threatening
24
Disabilities

First Report: 1965 · Latest Report: 20250815

What Are the Most Common ACETAMINOPHEN\ASPIRIN\CAFFEINE Side Effects?

#1 Most Reported
Product use in unapproved indication
3,758 reports (32.1%)
#2 Most Reported
Drug effective for unapproved indication
3,300 reports (28.2%)
#3 Most Reported
Drug ineffective
2,852 reports (24.4%)

All ACETAMINOPHEN\ASPIRIN\CAFFEINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Product use in unapproved indication 3,758 32.1% 1 18
Drug effective for unapproved indication 3,300 28.2% 0 1
Drug ineffective 2,852 24.4% 0 22
Drug dependence 567 4.9% 27 10
Incorrect dose administered 379 3.2% 2 7
Nausea 314 2.7% 0 21
Drug ineffective for unapproved indication 303 2.6% 0 3
Overdose 285 2.4% 4 41
Therapeutic response unexpected 274 2.3% 0 4
Abdominal discomfort 266 2.3% 0 6
Headache 265 2.3% 0 48
Product use issue 255 2.2% 0 8
Product quality issue 254 2.2% 1 5
Abdominal pain upper 243 2.1% 2 26
Off label use 234 2.0% 2 24
Wrong technique in product usage process 232 2.0% 0 0
Expired product administered 217 1.9% 0 2
Medication overuse headache 192 1.6% 0 4
Migraine 181 1.6% 1 14
Insomnia 177 1.5% 0 8

Who Reports ACETAMINOPHEN\ASPIRIN\CAFFEINE Side Effects? Age & Gender Data

Gender: 76.1% female, 23.9% male. Average age: 53.7 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\ASPIRIN\CAFFEINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 2 0 0
2002 1 0 1
2003 3 1 1
2004 1 0 0
2005 4 0 0
2006 5 1 1
2007 3 0 1
2008 4 0 0
2009 6 1 1
2010 5 1 3
2011 13 0 5
2012 17 0 1
2013 19 0 4
2014 95 1 19
2015 212 1 17
2016 184 0 15
2017 95 4 15
2018 111 3 15
2019 69 0 13
2020 134 8 4
2021 105 3 13
2022 42 3 3
2023 80 6 14
2024 54 1 20
2025 24 0 2

View full timeline →

What Is ACETAMINOPHEN\ASPIRIN\CAFFEINE Used For?

IndicationReports
Migraine 4,879
Product used for unknown indication 3,380
Headache 3,265
Pain 653
Tension headache 180
Back pain 126
Hangover 97
Sinus headache 68
Arthritis 63
Dysmenorrhoea 59

ACETAMINOPHEN\ASPIRIN\CAFFEINE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\BUTALBITAL ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\CAFFEINE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\CAFFEINE\CODEINE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\CAFFEINE\OPIUM ACETAMINOPHEN\ASPIRIN\CAFFEINE vs ACETAMINOPHEN\CAFFEINE\PROPYPHENAZONE

Official FDA Label for ACETAMINOPHEN\ASPIRIN\CAFFEINE

Official prescribing information from the FDA-approved drug label.